CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Tomo-E scan +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03993691
NCT03993691N/ACompleted

Wrist Fracture Evaluation With a Desktop Orthopedic Tomosynthesis System

University of North Carolina, Chapel Hill·interventional·Posted Jun 21, 2019·Updated Feb 3, 2023

In Brief

A clinical study evaluating Tomo-E scan and Radiograph for Fracture. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Trauma to the extremities such wrist, ankle, limb is very common and affects all population groups. It constitutes a significant public health issue. Standard radiography remains the basic imaging tool. However, as a 2-dimensional (2D) imaging modality it lacks sensitivity and specificity. Misdiagnosis rates are known to be high, especially for non-displaced fractures of the scaphoid and talus as well as erosions due to rheumatoid arthritis. Misdiagnosis leads to over treatment and unnecessary loss of productivity and quality of life including 6-12 weeks in a cast. Missed fractures can result in a chronic, non-healing fracture that may require surgical fixation and early arthritis of the joint. From a physician perspective, a missed diagnosis can result in a lawsuit and an expensive settlement/penalty. Computed tomography (CT) offers high resolution and excellent visualization of bone and joint morphology, and Magnetic Resonance Imaging (MRI) delivers soft tissue and cartilage visibility. However, cost, space and workflow related issues make them prohibitive for small orthopedic clinics. Although the radiation dose of a CT scan has been reduced considerably in recent years, it is still significantly higher than a regular radiograph. The whole-body scanners also have difficulties in imaging patients in portable and weight-bearing conditions. Dedicated extremity CT scanners have been commercialized recently in an attempt to address the current deficiency. They still suffer from higher cost and at such have a limited installation base.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFracture
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJun 21, 2019
Enrollment StartNov 5, 2019
Primary CompletionNov 3, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.0 years ago

Interventions

Tomo-E scandevice

High-resolution limited-angle tomography positioning and examination will vary depending on injury.

Radiographdevice

Standard of Care radiographic imaging of wrist.